GULP – experts united
Ihre Aufgaben
- Active participation in the preparation and finalization of Safety Update Reports (SUR) for submission
- Stock keeping unit (SKU) mapping reviews linked to sales data
- Manual calculation of doses sold and percentage incidences of adverse event reports
- Data integrity – pulling case line listings and performing data quality checks on cases in the PV database within the scope of SUR preparation
- Extraction and adaptation of SUR templates according to working instructions
- Reviewing regulatory information to ascertain PV related safety actions or requesting regulatory information from product responsible Regulatory Affairs (RA) managers
- Uploading and finalization of reports on shared portal
- Liaising and working closely with colleagues in RA and local PV teams to ensure the timely transmission SURs to competent authorities
- Support with the preparation of PV documents (e.g., Requests for PV Information (RPI), PV statements, Product Benefit Risk Evaluation Reports) and archiving all PV related communications
- Miscellaneous – pro-active collaboration with other PV Specialist colleagues on various tasks
Ihr Profil
- Associate degree in life sciences
- Experience working in a GMP/compliance environment subject to authority inspections and knowledge of legal PV requirements and PV report preparation
- Fluent in spoken and written English, fluency in German is an asset
- Good Understanding of MS Office tools and Electronic document management systems
- Residence in Germany
Was wir bieten
Time for change – time for a new job! You are a Pharmacovigilance Specialist and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: a secure job, fair compensation and exciting new tasks at an attractive international company in the Rhine-Main area. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.
- Option of permanent employment with our business partner
- Extensive social benefits, incl. Christmas and holiday bonuses
- Up to 30 days vacation per year
- Free online courses, e.g. “German as a foreign language”
To apply for this job please visit www.gulp.de.